On December 21, 2017, the “340B Protecting Access for the Underserved and Safety-net Entities Act” or the “340B PAUSE Act” (the “Bill”) was introduced in Congress. The Bill includes a moratorium on registration of certain new 340B hospitals and “child sites,” new 340B hospital reporting requirements, and new government reporting […]
Health Law Alert
A (Temporary) Sigh of Relief: Delay of the Revised Common Rule
On January 17, 2018, just two days before the revised Federal regulations governing the protection of human subjects (the “Revised Common Rule”) were set to go into effect, the U.S. Department of Health and Human Services and fifteen other Federal departments and agencies announced a six month delay of the […]
Updating Part 2: SAMHSA Issues another Final Rule
On January 3, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a final rule governing the Confidentiality of Substance Use Disorder Patient Records (Part 2). This final rule addresses the following areas of the Part 2 regulations: prohibition on re-disclosure of Part 2 information, and circumstances and […]
Patient Orders May Not be Sent by Text Message
The Centers for Medicare & Medicaid Services (CMS) recently reaffirmed its prohibition against “Licensed Independent Practitioners” (LIPs) issuing patient orders via text message. CMS clarified that “the practice of texting orders from a [LIP] to a member of the care team is not in compliance with the Conditions of Participation […]
Don’t Forget! Breach Reports Due March 1, 2018
As organizations continue to close the books for calendar year 2017, remember that covered entities must file all HIPAA breach reports with the U.S. Department of Health and Human Services Office for Civil Rights (OCR). If a covered entity experienced a breach (as defined in the data breach notification rule) […]